CRT-D Indication Expanded to Add Early HF

The FDA has expanded cardiac resynchronization therapy defibrillator (CRT-D) use to include mild or asymptomatic heart failure, granting it a new indication for left bundle branch block.

The expanded indication applied to three implantable devices, all made by Boston Scientific.

The company is required to conduct two post-approval studies to evaluate complications and long-term mortality in this heart failure population.

One study is to follow left bundle branch block patients who get CRT-D devices, using data from the National Cardiovascular Data Registry. The other is to compare CRT-D versus implantable cardioverter-defibrillators (ICDs) through five years of biannual follow-up of patients in the trial that led to approval.

Left bundle branch block patients represented 70% of the patients in the trial; they showed a 57% reduction in heart failure events or death compared with ICD use.

At the time these findings were released at the European Society of Cardiology meeting in 2009, leading cardiologists questioned whether a broad expansion of the indication would be justified.

Cost was expected to be an issue, since CRT technology adds an estimated $7,500 to an already hefty $20,000-to-$25,000 price tag for an ICD.

Moreover, physicians who treat heart failure have been slow to embrace ICD-CRT even for highly symptomatic patients. It has been reported that roughly 60,000 devices are implanted annually in a patient population estimated at five million, half of whom are believed to have advanced disease.

The FDA cautioned that CRT-D devices are not a replacement for heart failure pharmacotherapy.

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